The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Porcelain Artificial Teeth.
Device ID | K823744 |
510k Number | K823744 |
Device Name: | PORCELAIN ARTIFICIAL TEETH |
Classification | Teeth, Porcelain |
Applicant | DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELL |
CFR Regulation Number | 872.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-13 |
Decision Date | 1982-12-28 |